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Completed

NCT Number: NCT03951922

Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain

The purpose of this quasi-experimental study is to explore the impact of a therapeutic horticulture program as an occupation-based intervention to address chronic pain symptoms for cancer survivors. The main objectives are to assess participants' perceptions of pain, physical and psychosocial wellness, stress management, and quality of life at pre-, post-, and 3-month follow-up. Quantitative and qualitative data will be synthesized and analyzed to explore this phenomenon.

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Key information

Conditions

Cancer Survivor Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92350, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 - 64 years of age
  • History of cancer diagnosis
  • Chronic pain longer than 3 months
  • Have interest in therapeutic horticulture and exercise
  • Able to participate in a moderate physical activity in sitting and/or standing for at least one hour twice a week
  • Able to provide own transportation to the horticulture site or the supervised exercise program
  • Able to comprehend, speak and write in English

Exclusion criteria

  • Uncontrolled seizure disorder
  • Pregnancy

Treatment and study plan

Horticultural activity

Behavioral

Therapeutic horticulture activities are plant-related activities that include but not limited to digging, watering, planting, weeding, trimming, fertilizing, mulching, harvesting, learning about organic farming, and exploring options to incorporate horticulture into daily activities

Primary outcomes

  1. Salivary Cortisol Test

    Time frame: Change between baseline and three months

    Participant stress level will be determined by salivary cortisol levels. Participant's salivary cortisol level will be measured at awakening, 30 minutes following awakening and bedtime. Typically, there is Cortisol Awakening Response (CAR), which is a steep rise in cortisol output during the first 30 minutes following awakening, followed by a steady decline across the morning, afternoon, and evening hours, with the daily nadir typically occurring around midnight. Flattened diurnal cortisol slope relates to increased emotional and psychosocial stress and related to worse health outcomes.

    The typical Cortisol Awakening Response (CAR) is defined as an increase of at least 2.5 nmol/l from the cortisol level taken at awakening. Although there are no agreed norms for the absolute concentrations of free cortisol in saliva it typically ranges between 4.7-18.5 nmol/l for post-awakening, between 8.6-21.9 nmol/l for 30 minutes post-awakening, and 0.3-15.2 nmol/l for bedtime.

Secondary outcomes

  1. Lower body strength

    Time frame: Change between baseline and three months

    Chair Stand testing measures the strength of the lower body. Average scores for this testing are 15 reps for women and 16 reps for men.

  2. Upper body strength

    Time frame: Change between baseline and three months

    Arm Curl testing measures the strength of the upper body. Average scores for this testing are 16 reps for women and 19 reps for men.

  3. Endurance

    Time frame: Change between baseline and three months

    2 Minutes Step testing measures the endurance or physical stamina. Average scores for this testing are 91 times for women and 101 times for men.

  4. Lower body flexibility

    Time frame: Change between baseline and three months

    Chair Sit and Reach testing measures lower body flexibility, specifically your hamstring flexibility. Average scores for this testing are +2 inches for women and + 0.5 inches for men.

  5. Upper body flexibility

    Time frame: Change between baseline and three months

    Back Scratch testing measures the flexibility of the upper body. Average scores for this testing are -0.5 inches for women and -3.5 inches for men.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Exploring the Effect of Occupational Therapy and Horticulture for Cancer Survivors With Chronic Pain

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 16, 2019
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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